Course curriculum

    1. Introduction

    2. Training Objectives

    1. History of ICH GCP

    2. Introduction to Good Clinical Practice

    3. Key Principles in GCP

    4. Good Clinical Practice Definitions

    1. GCP Requirements for Qualifications and Agreements by Principal Investigator

    2. GCP Requirements for Adequate Resources and Medical Care of Study Participants

    3. GCP Requirements for Communication with the IRB/IEC

    1. GCP Requirements for Informed Consent

    2. Informed Consent Requirements for Vulnerable Special Populations

    1. GCP Requirements for Compliance with the Protocol

    2. GCP Requirements for Compliance of Investigational Products

    3. GCP Requirements for Compliance with Randomized and Unblinding Procedures

    1. GCP Requirements for Source Data and Source Documentation

    2. GCP Requirements for Essential Documents

    3. GCP Requirements for Safety Reporting

About this course

  • $125.00
  • 20 lessons
  • 120 minutes
  • “This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors."

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